At the baseline and follow up visits (months 1, 3 and 6), the patients underwent complete ophthalmic examination and OCT evaluation. All patients were treated with bilateral PRP administered in three sessions according to ETDRS guidelines. Intravitreal injections of RBZ were given in one randomly selected eye at weeks 1 and 4 (group 1). The fellow eye received sham treatments (group 2). The Wilcoxon Signed Rank test was applied to compare the difference in VA and CRT between baseline and Month 6.

Results

Thirty patients (n= 56 eyes) completed the study; four eyes did not have complete VA and OCT data. Baseline demographics were well balanced between the groups (Table 1). In eyes with clinically significant macular edema (CSME) and CRT greater than 250µm, VA increased by 4.1 letters in group 1 (p=0.02) and decreased by 5.0 letters in group 2 (p=0.01) at the primary endpoint (month 6). In group 1, CRT decreased by 52 um (p=0.001), whereas in group 2, there was no significant change in thickness (p=0.09). In eyes without edema (no CSME and CRT≤250 µm), VA improved by 8.3 letters at month 6 in group 1 (p=0.05), with no significant change in group 2 (ΔVA =-1.6, p=0.69). The CRT showed no significant changes in both groups: group1, ΔCRT=1.9, p= 0.58 and group 2, ΔCRT=17.1, p=0.19. The proportion of eyes with development of VH was lower in group 1 when compared to group 2 (10% vs 23%, p=0.16).

Conclusions

Intravitreal RBZ in conjunction with PRP can be an effective combination treatment in eyes with PDR and CSME.